Trial Outcomes & Findings for ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK (NCT NCT03287271)
NCT ID: NCT03287271
Last Updated: 2026-07-31
Results Overview
Safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
28 days
Results posted on
2026-07-31
Participant Flow
Participant milestones
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Screen Failure
|
2
|
0
|
Baseline Characteristics
ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
Baseline characteristics by cohort
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
n=4 Participants
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
n=2 Participants
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=9 Participants
|
60.5 years
n=27 Participants
|
60 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 28 daysSafety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
Outcome measures
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
n=4 Participants
Defactinib (VS-6063) (200 mg) +Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
n=2 Participants
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Dose-Limiting Toxicity
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: the outcome measure is Phase 2-specific, study was terminated prior to Phase 2 initiation and, therefore, no data were collected for Phase 2
Outcome measures
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) +Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: the outcome measure is Phase 2-specific, study was terminated prior to Phase 2 initiation and, therefore, no data were collected for Phase 2
Outcome measures
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) +Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
To Assess the Toxicity and Adverse Event Profile of VS-6063 Plus Paclitaxel and Carboplatin Chemotherapy (Measured Via Adverse Events)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: the outcome measure is Phase 2-specific, study was terminated prior to Phase 2 initiation and, therefore, no data were collected for Phase 2
Outcome measures
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) +Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
To Describe Health-related Quality-of-life (QoL) Outcomes of Patients Receiving VS-6063 Plus Paclitaxel and Carboplatin Chemotherapy. (Measured Via Questionnaire)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: the outcome measure is Phase 2-specific, study was terminated prior to Phase 2 initiation and, therefore, no data were collected for Phase 2
Outcome measures
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) +Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: the outcome measure is Phase 2-specific, study was terminated prior to Phase 2 initiation and, therefore, no data were collected for Phase 2
Outcome measures
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) +Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
0 Participants
|
—
|
Adverse Events
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
n=4 participants at risk
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
n=2 participants at risk
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Colonic Obstruction
|
25.0%
1/4 • 22 months
|
50.0%
1/2 • 22 months
|
|
Blood and lymphatic system disorders
Elevated White Blood Cell Count
|
25.0%
1/4 • 22 months
|
0.00%
0/2 • 22 months
|
Other adverse events
| Measure |
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
n=4 participants at risk
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
n=2 participants at risk
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
VS-6063: Phase 1:
* First 3 patient cohort: VS-6063 200 mg PO twice daily
* IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Paclitaxel: Phase 1:
* First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Carboplatin: Phase 1:
* First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
* IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
75.0%
3/4 • 22 months
|
0.00%
0/2 • 22 months
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
25.0%
1/4 • 22 months
|
0.00%
0/2 • 22 months
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • 22 months
|
50.0%
1/2 • 22 months
|
|
General disorders
Fatigue
|
25.0%
1/4 • 22 months
|
0.00%
0/2 • 22 months
|
Additional Information
Michael McHale, MD
University of California, San Diego
Phone: (858) 822-5354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place